Cleared Traditional

Pain Freeze™, Medium Stream Spray, Model #2101 (K162218) - FDA 510(k) Clearance

Also marketed or referenced as:
Pain Freeze™, Mist Spray, Model #2102
K162218 · Nuance Medical, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
106d
Days
-
Risk

K162218 is an FDA 510(k) clearance for the Pain Freeze™, Medium Stream Spray, Model #2101. Classified as Vapocoolant Device (product code MLY).

Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on November 22, 2016 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuance Medical, LLC devices

Submission Details

510(k) Number K162218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date November 22, 2016
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 8
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K162218.
Vapocoolshot Mist
K193349 · Vapocoolshot, Inc. · Apr 2020
Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
K190161 · Gebauer Company · May 2019
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
K172598 · Itw Contamination Control Electronics · Apr 2018